Platelet Rich Plasma for Foot Ulcer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMarcus L. Gitterle, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Estar Medical dba Medical Technologies, LTD

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2, mild to moderate, neuroischemic diabetic chronic foot ulcers in subjects with Type 1 and Type 2 Diabetes Mellitus. The main question\[s\] it aims to answer \[is/are\]: Measure 1: Wound Closure with Tropocells Autologous PRF System for DFU Measure 2: Safety of Tropocells Autologous PRF System for DFU Researchers will enroll to acquire approximately 30 evaluable subjects with no comparison group. Run-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, for standard of care. Active Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic to receive standard of care with Tropocells Autologous PRF System. Follow-up Phase (1 month and 3 months): participants with wounds that losed during the Active Treatment Phase ( 100% wound closure with two weekly assessments demonstrating persistent closure) will be advanced to the follow-up phase to show if the wound remains closed at 1 month and 3 months.

Research Team

Adrianne P Smith, MD

Principal Investigator

Cascade Research Enterprise, LLC

Marcus L. Gitterle, MD

Principal Investigator

WoundCentrics

Eligibility Criteria

This trial is for males and females aged 18-80 with Type 1 or Type 2 Diabetes Mellitus who have chronic neuroischemic diabetic foot ulcers graded as mild to moderate (Wagner Grade II). Participants should not show at least a 20% wound reduction during a run-in phase to qualify for the active treatment.

Inclusion Criteria

I don't have signs of infection in my wound or limb.

I use a special boot or device to relieve pressure on my foot.

I am able to bear children, not pregnant, and will use birth control or abstain during the trial.

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Exclusion Criteria

I have not had sepsis in the last 2 weeks.

I have a history of blood clotting issues or am on IV heparin.

I have had radiation or chemotherapy in the last 3 months.

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Treatment Details

Interventions

Tropocells Autologous Platelet-rich Fibrin (PRF) (Platelet-rich Fibrin)

Trial OverviewThe study tests Tropocells Autologous Platelet-rich Fibrin (PRF) in wound care. It involves an initial run-in phase, followed by up to 12 weeks of treatment with PRF for those whose wounds don't shrink by at least 20%, and then follow-up after wound closure at one and three months.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: T1DM,T2DM participants with non-infected, neuroischemic, chronic foot ulcersExperimental Treatment1 Intervention

During Screen-the participant will be treated with standard of care (SOC) for 2 weeks, including education, nutritional supplement, weekly wound assessments and care with off-loading. After the two weekly visits, subjects who meet the inclusion/exclusion criterion, show adequate perfusion and area reduction less than 20%, and comply with the standard of care will be enrolled in the Active Treatment Phase. During the Active Treatment Phase, subjects will be treated weekly with TropoCells® Autologous Platelet-rich Fibrin (PRF) for twelve (12) weeks and continued SOC. Wound area will be documented with measures and photographs before and after cleansing and debridement (as needed). Clean wounds treated topically with active therapy will be covered with a non-adherent layered absorbent foam dressing with an external protective third layer. Mild compression will be applied with continued off-loading at least 2 week after closure. Follow-up evaluation after closure at 1 and 3 months.